TEST COMPLIANCENCT05921630
Patient Compliance With the Spirometry Protocol
A study testing Education in people with TEST COMPLIANCE, run by University of Gaziantep at 1 site in Turkey (Türkiye).
Trial summary
OBJECTIVE: In this study, the effect of brochure-based and video-assisted information given before spirometry on patient compliance will be evaluated. PATIENTS AND METHODS: This is a randomized controlled clinical trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- TEST COMPLIANCE
- What is being tested?
- Education
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2021to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients sent to the spirometry laboratory for forced vital capacity maneuver
Who cannot join
- illiterate and had communicational, hearing and visual impairment were excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Pre-Test Information on Patient Compliance With the Spirometry Protocol: A Randomised Controlled Clinical Trial
OBJECTIVE: In this study, the effect of brochure-based and video-assisted information given before spirometry on patient compliance will be evaluated.
PATIENTS AND METHODS: This is a randomized controlled clinical trial. Before the test, subjects in the intervention groups will be shown a brochure explaining the steps of the spirometry protocol and a video prepared for the same purpose. Standard routine information will be given to the control group by the technician before spirometry.
RESULTS: 450 patients will be included in the study. It will be investigated whether there is a difference in terms of test compliance between compliance status and age, gender, smoking status, presence of lung disease, spirometry indication, having spirometry for the first time and those receiving brochure, video and brochure-video information. Multivariate analyzes will be performed among the parameters found to be significant.
- Conditions
- TEST COMPLIANCE
- Being tested
- Education
- Keywords
- Patient education, respiratory function tests, spirometry, test failure, lung function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
Patient education before pulmonary function test
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Control group The control group was given standard routine information by the technician before spirometry. Receives: Other: Education |
| Leaflet group | Experimental | Information via leaflets: The subjects were given a leaflet prepared by the researchers based on literature review . The leaflet contained written and visual information about the steps of spirometry. The patients then underwent routine spirometry. Receives: Other: Education |
| Video | Experimental | Video-assisted education: Using a mobile phone, patients were shown a two-minute video prepared by the researchers in accordance with the guidelines that demonstrated how spirometry is performed. Receives: Other: Education |
| Leaflet + Video | Experimental | Education via leaflets + video: Subjects in this group were first given a leaflet and shown the video. They later underwent routine spirometry. Receives: Other: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient spirometry test compliance
We planned to increase patients' compliance with the spirometry test.
Measured: One year
Secondary outcomes (1)
Number of spirometry test repetitions
We planned to reduce the number of spirometry tests patients.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start1 Dec 2021
- Primary completion1 Sep 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TEST COMPLIANCEStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibel Doğru, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05921630
- Sponsor's protocol ID
- SDOGRU-001
- Status last verified
- Jun 2023
- First submitted
- 12 Jun 2023
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dogru S, Aytac S, Al-Haithamy SAA, Ovayolu O, Sezgi C, Taylan M, Uyar M. Impact of pre-test information on patient compliance with the spirometry protocol: a randomized controlled clinical trial. Eur Rev Med Pharmacol Sci. 2023 Oct;27(20):9754-9761. doi: 10.26355/eurrev_202310_34147.
PubMed 37916339
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pre-Test Information on Patient Compliance With the Spirometry Protocol: A Randomised Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05921630
- Acronym / sponsor ID
- SDOGRU-001
- Conditions
- TEST COMPLIANCE
- Keywords
- Patient education, respiratory function tests, spirometry, test failure, lung function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 27 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OBJECTIVE: In this study, the effect of brochure-based and video-assisted information given before spirometry on patient compliance will be evaluated.
PATIENTS AND METHODS: This is a randomized controlled clinical trial. Before the test, subjects in the intervention groups will be shown a brochure explaining the steps of the spirometry protocol and a video prepared for the same purpose. Standard routine information will be given to the control group by the technician before spirometry.
RESULTS: 450 patients will be included in the study. It will be investigated whether there is a difference in terms of test compliance between compliance status and age, gender, smoking status, presence of lung disease, spirometry indication, having spirometry for the first time and those receiving brochure, video and brochure-video information. Multivariate analyzes will be performed among the parameters found to be significant.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Other: EducationControl group The control group was given standard routine information by the technician before spirometry. |
| Leaflet group | Experimental | Other: EducationInformation via leaflets: The subjects were given a leaflet prepared by the researchers based on literature review . The leaflet contained written and visual information about the steps of spirometry. The patients then underwent routine spirometry. |
| Video | Experimental | Other: EducationVideo-assisted education: Using a mobile phone, patients were shown a two-minute video prepared by the researchers in accordance with the guidelines that demonstrated how spirometry is performed. |
| Leaflet + Video | Experimental | Other: EducationEducation via leaflets + video: Subjects in this group were first given a leaflet and shown the video. They later underwent routine spirometry. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients sent to the spirometry laboratory for forced vital capacity maneuver
Key exclusion criteria (1 listed)
- illiterate and had communicational, hearing and visual impairment were excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EducationPatient education before pulmonary function test | Other | Control group, Leaflet + Video, Leaflet group, Video |
Primary outcome
Patient spirometry test compliance
Time frame: One year
We planned to increase patients' compliance with the spirometry test.
1 secondary outcome
Number of spirometry test repetitions
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Derived from this study: PubMed 37916339Dogru S, Aytac S, Al-Haithamy SAA, Ovayolu O, Sezgi C, Taylan M, Uyar M. Impact of pre-test information on patient compliance with the spirometry protocol: a randomized controlled clinical trial. Eur Rev Med Pharmacol Sci. 2023 Oct;27(20):9754-9761. doi: 10.26355/eurrev_202310_34147.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with TEST COMPLIANCE, run by University of Gaziantep at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient spirometry test compliance (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05921630, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2023.